Pulmonary Hypertension study: Pioglitazone vs Labs
Official title Bioenergetic Effect of Pioglitazone in CLD-PH
ClinicalTrials.gov ID: NCT06336798
What this study is testing
What is Pioglitazone 30 mg?
An investigational daily oral medicine being studied for pulmonary hypertension due to chronic lung disease.
Also referred to as Actos.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if pioglitazone is safe and whether it changes how cells use oxygen in these patients.
- Who it's for
- Adults who have pulmonary hypertension that comes from chronic lung disease.
- What's involved
- Participants will take either pioglitazone or a placebo once a day for 28 days, then switch to the other for another 28 days after a 2‑week break.
- Time commitment
- The total study lasts about 8 weeks, with two 28‑day treatment periods and a 2‑week washout in between.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of a signed and dated informed consent form
- Stated willingness to comply with all study procedures for the duration of the study
- Confirmed to have pulmonary hypertension (PH) due to chronic lung disease at screening
- Mean pulmonary artery pressure \>20 mmHg
- Pulmonary artery wedge pressure ≤15 mmHg
You likely can't join if
- Diabetes mellitus (type 1 or type 2), present within the preceding 1 year
- Personal history of symptomatic hypoglycemia within 90 days preceding enrollment
- Personal outpatient use of pioglitazone, rosiglitazone, metformin, insulin, or other medications for the indication of diabetes within 90 days...
- History of left ventricular failure (systolic or diastolic)
- Pulmonary hypertension due to Group 2 PH (PH due to left heart disease)
- History of prior or active bladder cancer
See the full eligibility criteria
- Provision of a signed and dated informed consent form
- Stated willingness to comply with all study procedures for the duration of the study
- Confirmed to have pulmonary hypertension (PH) due to chronic lung disease at screening
- Mean pulmonary artery pressure \>20 mmHg
- Pulmonary artery wedge pressure ≤15 mmHg
- Pulmonary vascular resistance \> 2 Wood units
- Pulmonary hypertension is classified in Group 3: PH associated with lung diseases and/or hypoxia
- Medications approved for the treatment of pulmonary hypertension must be at a stable dose for at least 30 days
- Ability to take oral medication and be willing to adhere to the study intervention regimen
- For females of reproductive potential: agreement to use highly effective contraception during study participation and for an additional 4 weeks after the end of study participation.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner
- Agreement to adhere to Lifestyle Considerations (below) throughout the study duration o During this study, participants are asked to arrive in the clinic for study visits in the fasting state.
- Diabetes mellitus (type 1 or type 2), present within the preceding 1 year
- Personal history of symptomatic hypoglycemia within 90 days preceding enrollment
- Personal outpatient use of pioglitazone, rosiglitazone, metformin, insulin, or other medications for the indication of diabetes within 90 days preceding enrollment
- History of left ventricular failure (systolic or diastolic)
- Pulmonary hypertension due to Group 2 PH (PH due to left heart disease)
- History of prior or active bladder cancer
- Thrombocytopenia (diagnosis or known platelet count ≤120) within 90 days preceding enrollment
- Platelet count ≤120 during screening or on the day of enrollment hypertension due to chronic lung disease
- Cystic fibrosis
- Pregnancy or lactation
- Current tobacco use
- Known allergic reaction to components of the study medication (pioglitazone)
- Treatment with another investigational drug within 30 days
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.